UPC_CFI_681/2024
DATA PROCESSING, ANALYSIS METHOD OF GENE EXPRESSION DATA TO IDENTIFY ENDOGENOUS REFERENCE GENES
Parent infringement case:UPC_CFI_437/2024
GXD-Bio Corporation sued multiple Myriad Genetics entities for infringement of EP 3 346 403 B1 (a method for identifying endogenous reference genes using gene expression data) by Myriad's test kits used in breast cancer diagnosis. The Munich Local Division dismissed the infringement action because the accused products use a single-step average normalization rather than the patent's sequential three-step method; simultaneously, the patent was revoked on the Myriad counterclaim for seven UPCA territories, and the amendment application was also dismissed.
Myriad's test kits do not perform the patented three-step normalization method of claim 1 of EP 3 346 403
RespondentLegal basis: Art. 25 UPCA; claim construction; direct infringementNote: Court accepted that the accused products use a single-step average normalization across three reference genes, which differs from the patent's required sequential normalization against each individual reference gene; the method therefore does not embody the technical teaching.
Late-filed argument that the calculation is mathematically equivalent to the patented method must be disregarded
RespondentLegal basis: R. 9.2 RoPNote: Claimant's novel mathematical-equivalence argument raised for the first time at oral hearing was excluded as late-filed; defendants had no opportunity to respond.
Revocation counterclaim: EP 3 346 403 lacks validity
RespondentLegal basis: Art. 65 UPCANote: Patent was revoked in full for all seven requested territories (AT, BE, FR, DE, IT, LU, NL); the excerpt's outcome summary confirms revocation although detailed grounds are not in the visible excerpt.
Accused test kits directly infringe claim 1 because the average normalization is mathematically identical to successive per-gene normalization
ClaimantLegal basis: Art. 25 UPCA; claim constructionReason: Mathematical identity of results does not equate to use of the claimed method; the actual configuration (single-step average) is decisive, and the patented method requires further steps not performed by the accused product.
Indirect infringement: the test kit is suitable and intended for the patented method using OAZ1 alone as reference gene
ClaimantLegal basis: Art. 26 UPCA; indirect infringementReason: Claimant did not argue that the test kit, despite its materials and reagents, is suitable and intended for normalization against OAZ1 alone; indirect infringement therefore ruled out.
Genes CALM2 and RPL37A can serve as further reference genes under the patent's multi-reference-gene reading
ClaimantLegal basis: Claim construction; Art. 25 UPCAReason: The patent itself identifies CALM2 and RPL37A as candidate reference genes rejected for insufficient expression stability; using them as reference genes falls outside the claim's scope.
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Claim 1 of EP 3 346 403 requires a three-step normalization method in which the expression level of a target gene is normalized against each reference gene individually (sequentially). The court held this excludes a single-step average normalization using the mean of three reference gene expression levels, even if the numerical result is mathematically the same. Reference genes CALM2 and RPL37A were identified in the description as 'candidate' genes not selected as 'guide genes' due to insufficient expression stability, placing them outside the claim's scope.